Kornimate/medical-research-clean huggingface dataset:
improved recovery by iron following surgery with blood loss, the iris-trial

Conditions: Surgery; Liver Metastases; Liver Cancer; Pancreas Cancer; Aortic Aneurysm

Summary: the aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (ida) and per-operative blood loss. median blood loss following hepatopancreatobiliary (hpb) and complex aortic surgery typically range between 500-1000 ml. bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. for the iris trial, it is hypothesized that intravenously (iv) administered ferric carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the rbc transfusion. patients scheduled for elective hpb surgery or complex aortic surgery will be screened for eligibility and recruited into the study. by the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg ferric carboxymaltose or placebo. the primary endpoint is a composite of death, number of rbc transfusions, post-operative severe anemia (hb \<80 g/l) and fact-an quality of life (qol) five weeks after surgery, assessed by win ratio. the trial will also examine effects on; a) levels of hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\ 4000 ml) per-operative blood loss. recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up the coordinating center of the trial is the department of surgery at uppsala university hospital. participating sites are also linköping university hospital and lund university hospital, all in sweden. other sites may be added.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. male and female patients 3. weight \> 50 kg 4. \> 18 years of age 5. scheduled for complex aortic surgery, liver resection or pancreatic resection exclusion criteria: 1. short expected survival (less than six months) 2. intra-venous iron therapy within one month prior to surgery 3. severe anaemia (b-hb \<80 mg/l) prior to surgery 4. contraindication to ferric carboxymaltose according to smpc 5. iron overloading disorder, i.e. hemochromatosis 6. risk of small for size future liver remnant 7. pre-operative renal replacement therapy 8. enrolled in another drug or medical device study within 30 days prior to enrolment of the current study 9. another planned major surgical procedure before the five week follow up 10. unsuitable for inclusion according to the investigator 11. pregnancy
implementing an interdisciplinary eating disorder screening and treatment program for post-bariatric surgery patients in nova scotia

Conditions: Bariatric Surgery Patients; Disordered Eating Behaviors

Summary: the goal of this interventional study is to evaluate the treatment and evaluation for after metabolic surgery with eating disorders (team-ed) program, which is a combined screening and treatment program for managing disordered eating in adults who have recently had weight loss surgery in nova scotia. the main question it aims to answer is 'can an interdisciplinary program for screening, diagnosing, and treating disordered eating after weight loss surgery be implemented in nova scotia? this study will determine the feasibility and impact of the team-ed program by assessing the following objectives: 1. reach (how effectively the program engages the target population \[post-weight loss surgery patients\]) 2. effectiveness (the extent of the program's impact on key clinical outcomes related to disordered eating and weight management) 3. adoption (the extent to which the program is adopted and accepted by clinicians) 4. implementation (how consistent program delivery is and factors impacting consistent delivery) participants will complete a disordered eating screening questionnaire online every 3 months after weight loss surgery until they reach 18-months post-surgery. participants found to have disordered eating will be offered team-ed treatment (cognitive behavioral therapy, and treatment plan oversight by both weight loss surgery and eating disorder specialists). standard outcome measures will be collected at baseline, during eating disorder treatment, post-treatment, and at follow-ups. participants may also be asked to do a one-on-one research interview about their experiences with the program.


Eligibility criteria:
inclusion criteria: * ≥19 years old * between 3- and 18-months post-weight loss surgery. * able to complete english computer-based self-report questionnaires (with adequate accommodation, if necessary).
freedom® cervical disc use in the treatment of cervical degenerative disc disease

Conditions: Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7

Summary: this study will collect clinical and radiographic data on the freedom cervical disc to monitor the device's safety and performance as part of a post-market evaluation.


Eligibility criteria:
inclusion criteria: * skeletally mature males or females, aged 21 to 65 years old, inclusive. * single, or adjacent, 2-level degenerative disc disease at c3-c7, inclusive. * subject is a surgical candidate for an anterior approach to the cervical spine. * minimum of 6 weeks of unsuccessful conservative treatment. * subject with at least moderate preoperative pain and functional impairment * subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years. * subject must understand and sign the written informed consent form. exclusion criteria: * subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm). * an active infection at the operative site or active systemic infection at the time of surgery. * known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone. * previous spinal fusion at the involved, or adjacent, cervical level(s). * congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s). * significant osteoporosis in the cervical spine. * the investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation: * cervical facet degeneration of the involved c3-c7 levels. * previous trauma to, or fusion in, the c3-c7 levels. * cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays. * radiographic findings of a fused or total collapsed disc. * significant global cervical kyphosis (≥15º on cobb angle measurement) or significant reversal of lordosis. * female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years

Keywords: cervical ddd ddd degenerative disc disease c3-c7
compare sudden stopping and weaning of anticholinergics in recurrence of oab symptoms

Conditions: Voiding Disorders

Summary: our study included 60 patients with idiopathic oab and treated with solifenacin 5mg twice daily for one month. after improvement of their condition, we divided the responders into 2 groups, group i stopped the drug suddenly, while group ii underwent gradual weaning of the drug.

we started an open-label, prospective, two-arm, randomized controlled trial at beni-suef university, from january 2018 to january 2019, including 60 patients suffering from oab symptoms. patients were recently diagnosed with idiopathic oab which was not treated prior to enrollment. all participants signed written informed consents. the study protocol was approved by the ethics committee of our faculty. patients were allocated into 2 equal groups (30 patients in each group) according to a computer-generated random numeric table after exclusion of those who are not eligible or refused to be included in the study

Eligibility criteria:
inclusion criteria: * oab patients. * recently diagnosed. exclusion criteria: * previous trials of treatment * uti, stones, tumors, or infravesical obstruction.

Keywords: oab
effects of training dose on computerized cognitive training in patients with cognitive impairment

Conditions: Cognitive Impairment, Mild; Dementia

Summary: the goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. the main questions it aims to answer are: * is there an optimal dose of computerized cognitive training for patients with cognitive impairment? * is the optimal dose different in patients in different age populations? participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose. the researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities. the researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.

background: computerized cognitive training (cct) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. cct has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. however, there is a lack of research on the optimal training dose for people with cognitive impairment. previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment. objectives: the study aimed to explore the dose-response relationship of cct and estimate the optimal daily and weekly dose for people with cognitive impairment. participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. the exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. the weeks with the same training dose of different patients will be classified into one group of exposure. the mixed effects model will be used to estimate the optimal dose.

Eligibility criteria:
inclusion criteria: * patients with cognitive impairment. * patients who took computerized cognitive training in 2017-2022. * age ≥ 40 years * training duration ≥ 2 weeks exclusion criteria: * with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases
internet-based guided self-help for chronic tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to determine the efficacy of a cognitive behavioral guided self-help training provided via the internet on tinnitus distress in a german sample.

long waiting periods and the deficiency of outpatient therapies stimulated the development of internet-based interventions for a variety of mental disorders during the last years. a swedish research group developed an internet-based self-help training for patients with chronic tinnitus showing promising results (andersson et al., 2002; kaldo et al., 2007; kaldo et al., 2008). this self-help training was now adapted for german-speaking patients. the present study evaluates the efficacy of this treatment in a randomized controlled trial conducted in germany. further aims are a process evaluation of the treatment and the identification of predictors of efficacy.

Eligibility criteria:
inclusion criteria: * age of at least 18 years * chronic tinnitus for at least 6 months * medical examination of tinnitus by an ear, nose and throat physician (ent) * scoring 38 or above on the tinnitus handicap inventory (thi) or scoring 13 or above on the mini-tinnitus questionnaire (mini-tq) * not currently receiving psychological treatment for tinnitus * being able to access the internet and print instructions * sufficient knowledge of the german language to read and follow the internet-based self-help program exclusion criteria: * tinnitus caused by any other general medical condition or otologic disease (e.g., active meniere's disease) * clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis) * clinical diagnosis of dementia or another severe organic cerebral disorder * clinical diagnosis of substance-related addiction/abuse

Keywords: tinnitus internet training cognitive-behavior therapy cbt
renalof in the treatment of elderly patients with gallstones

Conditions: Cholelithiasis

Summary: the purpose of this study is to assess the efficacy and safety of renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged \>65 years). the duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. the estimated number of patients to be recruited and randomized for the study is 40.


Eligibility criteria:
inclusion criteria: * confirmation of cholelithiasis by ultrasonography with or without clinical symptoms. * signed informed consent exclusion criteria: * previous surgical intervention for the treatment of cholelithiasis * cholelithiasis with acute symptoms requiring emergency surgery * cholelithiasis associated with neoplastic condition of any localization or origin * usage of other antioxidants within the duration of the clinical trial * handicap and/or psychiatric condition preventing treatment accomplishment

Keywords: dietary supplement renalof gallstones elderly
proof of mechanism of a new ketogenic supplement using dual tracer pet (positron emission tomography)

Conditions: Mild Cognitive Impairment

Summary: a six month, placebo-controlled, parallel group project in which mci participants will receive 30 g/day of a custom-made mct-based ketogenic supplement or a matching placebo. uptake of both the brain's fuels - ketones (as 11c-acac) and glucose (as fdg) - both before and after the intervention will be assessed by pet (position emission tomography) ; imaging and ketone pharmacokinetic as primary objective as well as fmri, diffusion mri and cognition.


Eligibility criteria:
inclusion criteria: * subjective memory complaint * montreal cognitive assessment (moca) score of 18-26/30 or a mini-mental state exam (mmse) score of 24-27/30 * autonomy for activity of daily living * absence of depression exclusion criteria: * diagnosis of a major cognitive disorder * diseases or psychiatric disorders that could interfere with participation * uncontrolled diabetes (fasting plasma glucose \>7 mm or glycated hemoglobin \>6.5%) * major depression or history of alcohol or substance abuse within the past 2 years, * already supplementing with coconut oil or mct * vitamin b12 deficiency * uncontrolled hypertension, dyslipidemia, or thyroid disease, * visual or hearing impairment impeding comprehension * participation in another intervention trial * inability to lie down without moving for 60 min (for the brain imaging) * presence of implanted metal objects or devices contraindicated for mri (phase 1)

Keywords: mild cognitive impairment ketones medium chain triglycerides positron emission tomography magnetic resonance imaging cognition brain neuroimaging
a study to evaluate gsk1325760a - a long-term extension study

Conditions: Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Summary: the primary objective of this study is to evaluate the safety of long-term administration of gsk1325760a in patients with pah. the secondary objectives of this study are to evaluate long-term administration of gsk1325760a on: * improvement in exercise capacity (six-minutes walk distance: 6mwd), change in who functional classification and time to clinical worsening of pah * change in the borg dyspnea index (assessed immediately following the six-minute walk test \[6mwt\]) * change in plasma brain natriuretic peptide (bnp) levels * cardiopulmonary hemodynamics parameters (as measured by echocardiography)


Eligibility criteria:
inclusion criteria: * subjects who complete the 24-week administration of the phase ii/iii study (study no.amb107816) * subjects who are assessed that the long-term extension administration of gsk1325760a is appropriate in the judgement of the investigator or subinvestigator * subjects who request the long-term extension administration of gsk1325760a, and agree to newly sign the informed consent form exclusion criteria: * subjects who have been withdrawn from the phase ii/iii study. * female subjects who wish to become pregnant. * treatment with other pah medication is needed. * a worsening of 2 or more levels of the who functional classification (see appendix 2.1) comparing with the baseline of phase ii/iii study (study no.amb107816). * worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during phase ii/iii study (study no.amb107816). * rapidly progressing cardiac, hepatic or renal failure during phase ii/iii study (study no.amb107816). * participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.

Keywords: pulmonary arterial hypertension ambrisentan
allogeneic cord blood for neurological diseases in adults

Conditions: Neurological Diseases; Stroke; Spinal Cord Injuries

Summary: this open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.

neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. the investigators clinical research aims to determine the safety and efficacy of allogeneic umbilical cord blood for adult patients with neurological diseases such as stroke and spinal cord injury.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke (onset \< 24 months), or * spinal cord injury (onset \< 24 months) exclusion criteria: * raised intracranial pressure * malignant cancer * renal failure * severe pulmonary dysfunction

Keywords: adults
extending prostate genetic awareness, navigation, and delivery: the expand network

Conditions: Metastatic Prostate Carcinoma; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8

Summary: this trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among african american men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). while genetic testing has become central to prostate cancer care, african american men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. a network of peer genetic coaches may help address barriers, beliefs, and needs of african american men in the community and provide navigation to increase engagement in genetic testing.

primary objectives: i. identify and train 6 african american (aa) men as peer genetic coaches (pgcs) for the extending prostate genetic awareness, navigation, and delivery (expand) network. (train peer genetic coaches) ii. conduct a feasibility study of peer genetic coaching. (provide individual coaching) secondary objective: i. patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge. outline: aim 1: peer genetic coaches undergo training and education on study. aim 2: patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Eligibility criteria:
inclusion criteria: * aim 1: are 18 years old or older * aim 1: are able to read and speak english comfortably * aim 1: men who have experience with both prostate cancer (pca) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience * aim 2: are 18 years old or older * aim 2: are african american * aim 2: are able to read and speak english comfortably * aim 2: men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (t3 or higher, gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer exclusion criteria: * patients that do not meet the inclusion criteria * children under the age of 18 * anyone who has trouble understanding the consent or with significant anxiety detected during the consent process
sonographic differences in brain measurements between normal and intrauterine growth restriction (iugr) fetuses

Conditions: Intra-uterine Growth Restriction

Summary: intrauterine growth restriction is being suspected in cases where the fetal estimated weight is less then the 10 th percentile for its gestational age. abdominal circumference is the most influenced measurement in this cases. head circumference on the other hand can be or not be influenced. previous studies have shown that transverse cerebellar diameter (tcd) is constant to gestational age and is not influenced by iugr.other showed lower tcd in iugr fetuses. we would like to study the differences in cerebellar, vermian and corpus callosum growth between normal to iugr fetuses and between symmetrical and asymmetrical iugr. in this observational study we will include pregnant women between 28-37 gestational week with a singleton otherwise normal pregnancies. we will measure the fetal tcd, vermian distances and the cc, abdominal circumference, head circumference and femur length. we will compeer these measurements according to the following groups:normal fetuses, symmetrical and asymmetrical iugr.


Eligibility criteria:
inclusion criteria: * singleton, * 28-37 ga, * well dated pregnancy. exclusion criteria: * multifetal pregnancies, * no first trimester dating, * fetuses with known chromosomal or structural anomalies.

Keywords: iugr fetuses symmetrical iugr asymmetrical iugr